510(k) K070356
K070356 is an FDA 510(k) premarket notification submitted by Medwaves Incorporated for the device "MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 18, 2007. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Medwaves Incorporated has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 18, 2007
- Date Received
- Feb 6, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
- 510(k)